Short-term and Mid-term Outcome of Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique
研究概览
简要总结
The purpose of this study is to assess the percentage of pulmonary venous stenosis after TAPVC repair with sutureless closure.
详细描述
Parents of patients with TAPVC after repairing by sutureless technique will be informed about the study. If parents agree to participant in the study and sign the informed consent, the investigators will collect information of patients and echocardiography results at 1 month, 6 month, 12 month and 18 month after the operation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with TAPVC operated with sutureless closure and be agreed to join this study by parents from 01/2019 to 06/2024.
排除标准
- •TAPVC operated with sutureless closure have single ventricle, isomerism or heterotaxy, congenital pulmonary venous stenosis.
- •TAPVC enrolled to study but cannot the obtain the echocardiography at the time of 1 month, 6 month, 12 month and 18 month.
结局指标
主要结局
The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique
时间窗: The investigators assess the PVS at the time of 18 month after the operation.
The investigator calculate pulmonary venous score (PVS) based on the mean gradient through each pulmonary vein. Then we sum all the score of each pulmonary vein, range from 0 to 12, and classify to 4 levels. Score 0 if the mean gradient is less than 2mmHg, 1 if it is from 2 to 6,9mmHg, 2 if it is from 7 mmHg and above, and 3 if the vein is occluded. The degree of obstruction is classified as follow: none (0 to 1), mild (2 to 3), moderate (4 to 7), and severe (from 8 and above).
Early mortality (<30 days)
时间窗: 30 days
Early mortality is defined when patients die within 30 days since the operation
次要结局
- Late mortality (> 30 days)(The investigators assess mortality at the time of 18 month after the operation)
- The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique(The investigators assess the PVS at the time of 6 month after the operation.)
研究者
Thanh QL. Dinh, MD, Ms
Principle investigator
Children's Hospital 1